What is tofacitinib used for?

Indications and Usage, quoted from the label by Micro Labs Limited (ANDA209738). Cross-references to other label sections are left out.

Rheumatoid Arthritis

Tofacitinib tablets are indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use

Use of tofacitinib tablets in combination with biologic disease-modifying antirheumatic drugs (DMARDs) or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Psoriatic Arthritis

Tofacitinib tablets are indicated for the treatment of adult and pediatric patients 2 years of age and older with active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of tofacitinib tablets in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Ankylosing Spondylitis

Tofacitinib tablets are indicated for the treatment of adult patients with active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use

Use of tofacitinib tablets in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Polyarticular Course Juvenile Idiopathic Arthritis

Tofacitinib tablets are indicated for the treatment of pediatric patients 2 years of age and older with of active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use

Use of tofacitinib tablets in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Ulcerative Colitis

Tofacitinib tablets are indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers. Limitations of Use

Use of tofacitinib tablets in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Source: DailyMed label, set id ffa6819b-23a4-478b-8fb7-cc90e8142fc5, version 5, effective September 25, 2026. NDC 42571-268, one of 22 listings for this product.

Indications and Usage, quoted from the label by Zydus Pharmaceuticals USA Inc. (ANDA214264). Cross-references to other label sections are left out.

Rheumatoid Arthritis

Tofacitinib extended-release tablets are indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers.

Limitations of Use

Use of tofacitinib extended-release tablets in combination with biologic disease-modifying antirheumatic drugs (DMARDs) or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Psoriatic Arthritis

Tofacitinib extended-release tablets are indicated for the treatment of adult with active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.

Limitations of Use

Use of tofacitinib extended-release tablets in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Ankylosing Spondylitis

Tofacitinib extended-release tablets are indicated for the treatment of adult patients with active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers.

Limitations of Use

Use of tofacitinib extended-release tablets in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Ulcerative Colitis

Tofacitinib extended-release tablets are indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers.

Limitations of Use

Use of tofacitinib extended-release tablets in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Source: DailyMed label, set id 179ffbb2-bedc-40e6-b77b-33d4f7832172, version 7, effective August 7, 2026. NDC 70710-1353, one of 14 listings for this product.

Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA218407). Cross-references to other label sections are left out.

Psoriatic Arthritis

Tofacitinib oral solution is indicated for the treatment of pediatric patients 2 years of age and older with active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.

Limitations of Use

Use of tofacitinib oral solution in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Polyarticular Course Juvenile Idiopathic Arthritis

Tofacitinib oral solution is indicated for the treatment of pediatric patients 2 years of age and older with of active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers.

Limitations of Use

Use of tofacitinib oral solution in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Source: DailyMed label, set id a764a133-b870-4514-bbee-24d43f8cb7fd, version 5, effective October 16, 2026. NDC 70095-008, one of 5 listings for this product.